VMP (Validation Master Plan) Preparation Guideline in Pharmaceuticals

Validation Master Plan

VMP is a roadmap of validation activity like facility qualification and also define system and area to be validated. VMP justifies the strategy, documenting the necessary program. It’s a “high level” document which provides a written program to ensure a continuing state of validation. We can say VMP is achieving and maintaining qualified facility.

All Validation program is mention in VMP. In simple language we can describe the major element of “Validation program”-

Change control

Outline for process validation program

Acceptance criteria: A list of the general acceptance criteria for the validation tasks must comply to concisely define the completion of validation tasks. If possible, at this stage of project, specific acceptance criteria should be developed for each unit to be validated.

Revalidation

Planning and Scheduling

Validation schedule is the last but not the least important component of overall validation activity.

Qualification/Validation Report

A report that cross-references the qualification and/or validation protocol should be prepared, summarising the results obtained, commenting on any deviations observed, and drawing the necessary conclusions, including recommending changes necessary to correct deficiencies. Any changes to the plan/procedure as defined in the protocol should be documented with appropriate justification.

Deviation

Any deviations / critical changes to the approved protocol during the execution of process validation shall be handled as per handling of deviation procedure. Details of deviation shall be documented in the report with details such as, description of deviation, reason / cause, corrective and preventive action, and status of the deviation.

All the deviations shall be closed or resolution shall be specified prior to release of product for intended purpose.

Deficiency (If Any) and Corrective Action Report

During validation or qualification if any deficiency shall be observed, then following things must be recorded such as

1.0 Description of deficiency and date observed

2.0 Person, Responsible for corrective action and date assigned

3.0 Corrective actions taken and date conducted:

These are always approved by HOD of Quality Assurance.

Addendums to Protocols

Addendums are used during execution of a protocol in five instances:

Addendums are utilized to record additional data/test not initially written into the protocol, but will enhance the validation of the System/Equipment.

Addendums are utilized when a test was inadvertently left out of the initial protocol writing and the test is necessary to enhance the validation of the System/Equipment.

Addendums are utilized if a test initially written into the protocol cannot be performed or must be changed. The Addendum is utilized for detailing the new test and recording the data. Use of the Addendum in this manner requires approval by the Validation Taskforce leader prior to implementation and execution.

Addendums are utilized when more space is required to completely record data and/or comments.

The Addendums require the protocol name, protocol number, execution date, signature of the preparer, date, and signature of the approver and date.

Conditional Final Report (CFR)

The conditional Final Report (CFR) is utilized in a circumstance when the portion of the validation effort impacting equipment, systems, and/or processes needed to complete scheduling deadlines is completed within the acceptance criteria limits, but the entire protocol is not completed and approved.

The CFR provides conditional approval for use of the specific area of the equipment, system, or process required by the schedule. The CFR summarizes the observations, data, deviations, conclusions, and recommended actions resulting from execution of the specific area of the appropriate protocols for the equipment, system, or process being following departments or their designees as applicable: Engineering, Production, Quality Assurance, Quality Control, and/or Research and Development. The conditional review of the validation testing, take place during “sign off ” of results. CFR or FR is only a compilation of the signed off results.